Two thousand ten brought the realization of Obama’s labors into the lives of all Americans. Suddenly all of the rhetoric and campaigning and mudslinging from all sides provided an air of tangibility with respect to the newly signed healthcare reform law. Some of the most popular posts for 2010 on Doctor Pundit were related to the unveiling of issues surrounding the legislation — some immediate and some predictive. Concerning the latter, the cost of healthcare delivery under the new law was on the minds of many DP readers.

(#4) Report: Reform Bill to Cover More People, Cost More Than Projected

…HHS and Kathleen Sebelius are releasing a report that seems to contradict the CBO’s analysis on the long-term economic viability of the Obama reform bill. In adding over 30 million to the coverage rolls, the new Affordable Care Act may not control costs as keenly projected by the Democrats…

Avandia and its future also weighed heavily.

(#3) Report: Pharma Company Covered Up Known Cardiovascular Risks of Drug

GSK has always stuck to its guns in defending its assertions that statements like that are based upon faulty safety information gleaned from major trials casting the drug in a negative light — like the well-known RECORD trial, which found that the overall risk of cardiovascular death of Avandia was not statistically significant. That meta-analysis was commissioned by GSK at the request of the FDA.

Finally, the DP tribute to a medical pioneer garnered the second-most sets of eyes for 2010.

(#2) Robert Butler, MD, Medical Education Icon, Dead at 83

Butler was the first clinician who coined the term “ageism”, the result of such forward-thinking approaches to the geriatric patient that was characterized by the medical practice free of biased attitudes and treatment assumptions that, if employed today, would cause harm to many elderly patients receiving chronic medical care.

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In an otherwise dull year for novel drug development, GSK is making positive news; it plans to expand into the realm of pharmaceutical development for the treatments of rare disorders. While this seems very noble for what it is, one mustn’t forget the harsh realities facing pharma companies in the dawn of healthcare reform: an overall cessation of FDA fasttracking of new drugs, increasing cynicism of patent-extending agents, the increasing threat of lawsuits and other legal issues surrounding many high-profile agents in the past decade, and the growth of unforeseen competition in the pharma marketplace at the hands of reform (plan rebates, more restricted Medicare Advantage contracts, etc.).

So, any method by which a pharma company can grow as current output faces increasing competition even among generic agents, is bound to be a plus for the company securing funding for these initiatives. Glaxo said it plans to have a list of about 200 illnesses that its rare disease unit will target.

Reflecting a growing push into rare diseases by big drug makers, GlaxoSmithKline PLC (GSK) Monday said it has identified around 200 such disorders that offer the best opportunity for clinical, regulatory and commercial success. Marc Dunoyer, who heads Glaxo’s rare disease unit, which was established in February, said that “with less than 10% of patients with rare diseases currently being treated worldwide, we recognize the size of the challenge, but also the opportunity to deliver new medicines to patients.” There are between 6,000 and 8,000 rare diseases currently identified, affecting around 6%-8% of the world’s population. Patient populations suffering from such illnesses are clearly defined and relatively easy to identify, with 70% of rare disorders being genetic in origin. Many rare diseases also involve clear molecular targets.

Glaxo plans worldwide distribution plans to combat the enormous costs of producing, marketing, and distributing such drugs. | LINK

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The FDA has announced today Avandia’s official indication. After months of teetering on the brink of availability many times over, GSK’s once star performer has now been relegated to last-ditch status. As of today, Avandia will be restricted to patients with type 2 diabetes whose condition cannot be controlled with other medications. Further, The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Per the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos, the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Although it may be too early to determine what this ruling will mean for GSK, the FDA is clearly sending a message to the Pharma company with respect to its availability in the U.S.^[1]: further sales come with a hefty price. It’s hard to imagine many physicians determined enough to pursue dispensation of this drug when so many safer and saner options abound. | LINK

1. The European Medicines Agency [analogous to the U.S. FDA] has suspended the marketing authorization for the treatments, effectively ceasing any promotion and further availability there.

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Embattled pharma company GSK may be celebrating the continued availability of its once-blockbuster drug Avandia on the market, but it’s bemoaning the fact that the FDA is putting the breaks (halting recruitment) on a safety trial it has begun initiating in an effort to restore positive PR for its troubled drug. As part of its 20-12 ruling to keep the drug on the pharma market, the FDA is also requiring the IOM to investigate the ethics surrounding GSK’s commission of the trial.The study, though not officially canceled, is suspended while the FDA continues to soak in the data and come to its own definitive conclusions regarding the safety of Avandia. | LINK

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The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those risks were not deemed strong enough to warrant removal. Twelve of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven wanted to add stiffer language to the current label, and 10 wanted both stiffer language and restrictions on its use.

What is known now is that, according to the FDA, unless there is more long-term data on a link between Avandia’s use and cardiovascular death, there is nothing in terms of evidence currently convincing enough to warrant pulling the drug from the market. That’s the official statement by the agency, anyway.

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As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably say a lot about the process that leads to it. The latest salvos from Day 1?

An FDA scientist, speaking of GSK’s studies of the drug minimizing risk: You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.

GSK’s VP of Clinical Development: Our studies provide the most robust and reliable data  to assess Avandia’s safety, and those studies have found no evidence to suggest the drug increases the risk of heart attack or stroke in its users.

Testimony continues today with a decision expected on whether to pull the drug or apply restrictions to its use.

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GSK (then known as SmithKline Beecham) knew in a 1999 trial that Avandia, the drug undergoing scrutiny on its fate in the pharma marketplace today, posed a signficant cardiac risk when compared to its major competitor Actos — and it purposefully covered up that information. This, according to a report obtained by the NYT.

The reports … say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.

GSK has always stuck to its guns in defending its assertions that statements like that are based upon faulty safety information gleaned from major trials casting the drug in a negative light — like the well-known RECORD trial, which found that the overall risk of cardiovascular death of Avandia was not statistically significant. That meta-analysis was commissioned by GSK at the request of the FDA.

This is just the latest revelation in a very public battle over a Pharma company’s credibility in the healthcare marketplace and the validity of new information from a Senate investigation into that company’s handling of the trial results. Implications on who controls subsequent drug safety and treatment data years after a drug’s initial availability and what it means for the welfare of the public taking the drug versus pharma profits from the sale of the drug should be weighing greatly on the FDA panel making the decision on the drug’s ultimate fate. | LINK

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It’s official. The FDA will convene this Tuesday (13) to discuss and come to a decision on the fate of GSK’s Avandia. I guess you could literally call this agent a wonder drug — as its continued availability in the Pharma marketplace in spite of hundreds of class action lawsuits, multiple studies stretching back to at least 2005 documenting a clear association with an increase in heart attack risk, and copious physician calls for its withdrawal — continues to amaze healthcare policy watchers.

For the first time it appears that the handwringing on both sides of this hotly debated drug (Pharma/GSK vs. medical critics) appears to be taking on an overtly political tone, as even within the government agency itself, there is a deep devision over just how this entire case should be handled. The hoopla surrounding the removal of Vioxx and Bextra (anti-inflammatories with similarly documented cardiac risks) was never this contentious. Even U.S. senators have weighed in on the issue.^[1] What will the fate of this drug be? Tighter restrictions on its use, or complete removal from the pharma marketplace? Perhaps the answer says as much about the FDA as it does about GSK. | LINK

1. Sens. Baucus and Grassley published a report questioning the FDA’s rationale for keeping the drug available while GSK knew about the drug’s risks.

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A couple of weeks before the FDA meets to discuss the safety of the antidiabetic medication Avandia come (coincidentally) more reasons this agent should be withdrawn from the pharma marketplace. One study concludes that Avandia increased the risk of death, heart failure, stroke or heart attack by almost 20 percent compared with its main competitor, Actos. Another trial noting heart-attack risks associated with Avandia found that one of every 52 patients using the drug had an almost 33 percent increased risk of getting one.

Not to be outdone, the pharma manufacturer of Avandia — Glaxo Smith Kline — is standing by the troubled drug, releasing a statement saying that randomized trials show it is, indeed, safe; the American Diabetes Association agrees, saying there is no increase in overall mortality from the drug — independent of its effect on one’s risk of cardiovascular complications. Physicians have gone on record as being, at the very least, circumspect on the safety data trumpeted by GSK — noting flaws^[1] every step of the way. | LINK

1. Physician-critics have said the overall rate of cardiovascular problems among patients in the trial was suspiciously low. Many Avandia patients took statins — 10 percent more than the non-Avandia users — and those cholesterol-fighters are known to cut heart attack risk. Also, they say, a relatively high level of patients dropped out of the trial entirely, which could have compromised the results.

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What is known about the H1N1 epidemic that plagued the world in 2009 was its influence in global approach to this infection — for good or bad — and the costs to nations which chose to meet its threat head on. What wasn’t known at the time (but may be increasingly apparent if many European countries have their say) is that the trajectory of the influenza strain’s influence as a major media event may have been manufactured, by, of all entities, Pharma and its association with the World Health Organization. The concerns are outlined in an 18-page report criticizing costs deemed by many nations as unnecessary, as were “amplified” fears at the hands of the organization in galvanizing support for guidelines influenced by Pharma makers of the H1N1 vaccine.

Calling the WHO and its response to the H1N1 epidemic “exaggerated” and “lacking credibility”, many European nations are quite vexed that, among other things, guidelines issued by the WHO in response to what it termed as an epidemic came from consultants who received much in the way of fees from two leading Pharma manufacturers of the vaccine that would prevent the virus’s spread: Roche and GSK. The WHO has opened up its own international investigations into the matter — one of which involves the Institute Of Medicine on these shores.

The WHO asserts no potential for conflict of interest within its ranks, as this appears to be the central question in this entire matter. | LINK

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